Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial

Kohpar, Fatemeh Khazaei; Ghaffari, Kazem; Afzal, Roghayeh Rahimi; Eghbali, Aygin; Ghasemi, Ali

doi:10.1016/j.htct.2022.02.004

Cited by 2 publications

(3 citation statements)

References 26 publications

(31 reference statements)

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“…However, a reduction of gastrointestinal symptoms in children with acute diarrhea after the administration of probiotics has been reported 24,25 . Gastrointestinal side effects that are observed in many patients with cancer after chemotherapy affect the quality of life of patients to the extent that they can delay or stop treatment 20,26 . Gastrointestinal side effects have been reported in 40%–100% of patients with cancer, depending on the standard or high chemotherapy dose 2 .…”

Section: Discussionmentioning

confidence: 99%

“…24,25 Gastrointestinal side effects that are observed in many patients with cancer after chemotherapy affect the quality of life of patients to the extent that they can delay or stop treatment. 20,26 Gastrointestinal side effects have been reported in 40%-100% of patients with cancer, depending on the standard or high chemotherapy dose. 2 For example, it has been reported that about 50% of patients with cancer still have diarrhea and constipation after chemotherapy, whose episodes may continue up to 10 years after stopping treatment.…”

Section: Discussionmentioning

confidence: 99%

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The effects of LactoCare synbiotic administration on chemotherapy‐induced nausea, vomiting, diarrhea, and constipation in children with ALL: A double‐blind randomized clinical trial

Ghaffari

Khalilpour

Afzal

et al. 2023

Pediatric Blood & Cancer

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Background Synbiotics are supplements containing probiotics and prebiotics and potentially have a stronger effect in modulating the gut microbiota than probiotics or prebiotics alone. The aim of this study was to determine the effects of LactoCare synbiotic administration on chemotherapy‐induced diarrhea (CID), nausea, vomiting, and constipation in children with acute lymphoblastic leukemia (ALL) who receiving maintenance chemotherapy. Methods This double‐blind clinical trial was performed on 113 children with ALL. The patients were randomly assigned into two groups to receive either 5 × 109 CFU LactoCare synbiotic administration or placebo (58 patients in the LactoCare‐treatment group and 55 patients in the placebo group), twice a day for 7 days. The number of times CID, vomiting, nausea, and constipation were recorded in the first week after the beginning of receiving LactoCare and the placebo. Results In the LactoCare‐treatment group, CID was present in 3.7% and 1.8% of patients on the first and second days, respectively, and no CID was observed on the third to seventh days (p < .05). While in the placebo group, the rate of patients with CID on the second, third, and fourth days was 11.5%, 13.5%, and 11.5%, respectively, and less than 10% on the first, fifth, sixth, and seventh days. It was observed that the rate of constipation in the LactoCare‐treatment group was significantly lower than in the placebo group. The difference between the groups was about 14% on the third day, which increased to about 20% on the sixth day (p < .05). Conclusion The use of synbiotic supplements in this study reduced CID in patients. This study supports the concept that the use of synbiotic supplements will be an easy and effective way to reduce CID in ALL patients.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The effects of LactoCare synbiotic administration on chemotherapy‐induced nausea, vomiting, diarrhea, and constipation in children with ALL: A double‐blind randomized clinical trial

Ghaffari

Khalilpour

Afzal

et al. 2023

Pediatric Blood & Cancer

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“…More recently, the use of neurokinin-1 receptor antagonists has been recommended based upon the benefits of further reduction of CINV in adult and pediatric cancer patients ( 7 , 8 ). The two most commonly used drugs in this class of agents are oral aprepitant given daily for 3 days ( 9 ), and intravenous fosaprepitant given as a single dose. Fosaprepitant is a water-soluble prodrug that is converted by endogenous phosphatases into aprepitant following administration.…”

Section: Introductionmentioning

confidence: 99%

Comparison of oral aprepitant and intravenous fosaprepitant for prevention of chemotherapy-induced nausea and vomiting in pediatric oncology patients: a randomized phase III trial

Yu,

Wang,

Han

et al. 2024

Transl Pediatr

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Background Neurokinin-1 receptor antagonists have improved the management of chemotherapy-induced nausea and vomiting (CINV), but to date there has been no prospective comparison between oral aprepitant and intravenous fosaprepitant in pediatric oncology patients. Methods Our study was a double-parallel study, and the distribution ratio was 1:1. Children aged 2–12 years who were undergoing moderate or highly emetogenic chemotherapy (MEC or HEC) were randomly assigned to receive ondansetron and dexamethasone combined with either a single dose of intravenous fosaprepitant (arm A), or 3 days of oral aprepitant (arm B). The primary outcome measure was the rate of complete response (CR) of CINV within the acute phase, defined as from the start through 24 hours after the last chemotherapy dose. Response during the delayed phase, overall response, and use of rescue antiemetics were also assessed. Results We prospectively evaluated 108 eligible patients, including 55 receiving fosaprepitant. Study observations were made during a single cycle for each patient. The occurrence of CR in the acute phase was statistically higher for patients receiving fosaprepitant (95% vs. 79%, P=0.018<0.05). Modest differences were seen in CR rates during the delayed phase (71% vs. 66%, P=0.586), and overall response rate (69% vs. 57%, P=0.179). The use of antiemetic rescue medicines was similar between arms A (11%) and B (7%). Conclusions Fosaprepitant produced more CRs of CINV in the acute phase than did aprepitant, although there were no statistical differences in delayed phase response, overall response, or use of rescue antiemetics. This study confirms the safety, efficacy, and potential advantages of fosaprepitant in reducing CINV in pediatric oncology patients. Trial Registration ClinicalTrials.gov identifier: NCT04873284.

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Evaluating Aprepitant single-dose plus granisetron and dexamethasone in children receiving highly emetogenic chemotherapy for the prevention of chemotherapy-induced nausea and vomiting: A triple-blinded randomized clinical trial

Cited by 2 publications

References 26 publications

The effects of LactoCare synbiotic administration on chemotherapy‐induced nausea, vomiting, diarrhea, and constipation in children with ALL: A double‐blind randomized clinical trial

The effects of LactoCare synbiotic administration on chemotherapy‐induced nausea, vomiting, diarrhea, and constipation in children with ALL: A double‐blind randomized clinical trial

Comparison of oral aprepitant and intravenous fosaprepitant for prevention of chemotherapy-induced nausea and vomiting in pediatric oncology patients: a randomized phase III trial

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